Add-on Simvastatin in Schizophrenia Trial

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New York,
New York10032

Purpose:

The overall purpose of this study is to determine whether the cholesterol-lowering drug
simvastatin is effective in the treatment of symptoms of schizophrenia. The primary
hypothesis is that patients with schizophrenia receiving add-on treatment with simvastatin
will improve clinically (as measured mainly by symptom severity) compared with patients
receiving placebo, and that this improvement will be accompanied by concomitant reduction in
peripheral inflammatory markers.

Study summary:

The identification of alternative therapies with the capacity to dampen inflammatory
processes and reduce serum cholesterol takes on additional significance given independent
concerns about heightened cardiovascular risk in schizophrenia patients, through exposure to
antipsychotic drugs, increased cholesterol levels, metabolic syndrome and obesity, and
smoking.

Criteria:

Inclusion Criteria:
- Age 18-70 years
- Available for follow up during the study protocol
- DSM-IV schizophrenia
- Positive and Negative Syndrome Scale (PANSS) baseline score of ≥50
- Score of 3 or higher on the Severity of Illness scale of the Clinical Global
Impression (CGI)
- Not completely refractory to antipsychotics: evidence for at least partial
responsiveness to antipsychotic medication
- Evidence for current clinical stability
- Capacity to provide informed consent
- Provided informed consent
- Patients taking concomitant, non-investigational medications that are not listed in
Exclusion Criteria #1
- Patients speaking Spanish or English
- Women using acceptable methods of birth control, including barrier method
Exclusion Criteria:
- Currently taking a statin OR any of the following:
- Other lipid-lowering drug;
- Anti-inflammatory drugs or aspirin;
- Systemic antibiotic, anti-viral or anti-fungal drugs (within the past 4 weeks);
- Potent inhibitors of the cytochrome P450 isoform 3A4 (CYP3A4);
- Digoxin (Lanoxin®), nefazodone (Serzone®), niacin, cyclosporine (Neoral®,
Sandimmune®), danazol, warfarin (Coumadin®), amiodarone, verapamil, Cordarone®,
or Inderal®.
- Patients with known hypersensitivity to simvastatin or any other statin drug
- Active liver disease or unexplained persistent elevations of serum transaminases
- Renal insufficiency
- Serious or unstable medical condition that require close medical attention, such as
cancer, unstable heart failure, uncontrolled hypertension/asthma/COPD
- Current drug use disorder (abuse/dependence)
- Pregnancy and lactation
- Psychiatric disorders other than schizophrenia or schizoaffective disorder requiring
pharmacotherapy
- Suicidal or homicidal intent
- Severe cognitive impairment that might compromise competency to sign informed consent
or the validity of the cognitive outcome measure
- Organic brain disorder, including epilepsy; mental retardation; or a medical
condition whose pathology or treatment would likely alter the presentation or
treatment of schizophrenia
- Current participation in another clinical trial
- Patients on more than 2 anti-psychotic medications (patients will not be tapered off
effective medications for the purpose of participating in research)
- LDL cholesterol >100 mg/dL with known coronary hard disease. LDL cholesterol >130
mg/dl with 2 or more of the following risk factors: smoking; hypertension; low HDL
cholesterol (<40 mg/dL); age >45 years (men) or age >55 years (women); family history
of premature CHD (CHD in 1st degree relative male<55; female <65